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148 - Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.
• Jennifer Carroll -
135 - I am developing a web site to host presentations of specialists to family physicians. The website will be gated to only allow physicians and the presentations will be accredited by the College of Family Physicians and produced independently by the speaker. There will be space for physicians' comments as well discussion forums focussed around the the topics being presented. I will seek pharma sponsorship of the presentations and will declare the sponsorship on the pages where members access the presentations. Will the slides require PAAB approval and do you see any hurdles that I may face in this endeavour?
• Jennifer Carroll -
129 - Can sales representatives distribute Congress reports? The congress reports are commissioned by a pharma company to a third party ( ex medical communications company). Information is not focussed on company brands and is balanced and independently produced.Do these reports need to go to PAAB for reps to be able to distribute?
• Jennifer Carroll -
93 - As follow-up to question 91 and as referenced in question and answer 46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?
• Jennifer Carroll -
91 - Can sales representatives distribute educational materials that have been commissioned by their pharma company. The content of the educational material is produced by an independant expert faculty in a given disease area and content is reviewed by an University for balance & scientific integrity and endorsed as being deemed appropriate for Mainpro 2 or Section 2 credits. For reps to be able to distribute the information do the materials need to be reviewed by PAAB even though they are not promotional but rather educational?
• Jennifer Carroll -
84 - Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB's rules around distribution of these types of articles by drugmakers representatives.
• Jennifer Carroll -
69 - The CFPC has reviewed and approved a program for Mainpro-M1 credits and is awaiting final accreditation by the College's provincial chapter. Are materials used within the program (e.g. Slide Kit) exempt from PAAB review in the following cases: • Case 1 - Distributed to participants at the accredited event or at a later date? • Case 2 - Distributed to non-participants by sales reps?
• Jennifer Carroll -
46 - As a follow up to Question 45, if the off-label content of a peer reviewed journal article is not the focus and will not be discussed by the rep, can a disclaimer be added indicating that the product should not be used off-label, any off-label content is not applicable in Canada and to refer to appropriate product monographs?
• Jennifer Carroll -
41 - Just looking for some clarification on PAAB review of health education material (CME accredited, third party accrediated workshops, etc.). When sent in for review, will PAAB be providing an opinion only, or would it be acceptance of the material under review? Additionally, will existing printed material need to be sent to PAAB for review, or is just newly created material that has this requirement of review? Thanks in advance for the help in answering.
• Jennifer Carroll -
38 - Regarding Representative distribution of CME Accredited Materials: Can a program supporter have their representatives distribute or base discussions on CME accredited materials ? If I look at the these points it is unclear to me if indeed there can be representative involvement if so, at what level? :1.5(2) Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date. 1.5(3) If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.
• Jennifer Carroll -
36 - In your answer to question 34, you state "If the information is created independently of the company it is usually not advertising." I can think of clear examples of "text or reference books" that are produced by an independent publisher, but which deal almost exclusively with a single pharmaceutical product. If such items are paid for and distributed by company representatives, even though produced independently, are they advertising?
• Jennifer Carroll -
34 - Heatlh Canada has issued a policy entitled "Distinction Between Advertising and Other Activities" which states that " No one factor in itself will determine whether or not a particular message is advertising. Each message must be evaluated on its own merit and other factors may apply." An earlier response in this forum suggested that if it was a single sponsored publication, it was quite likely to be advertising if it dealt with therapeutics (you used the term "rarely" to describe the incidence with which you have seen non-promotional single-sponsored 3rd Party pieces.) Here's my question - if it is a single sponsored publication and mentions both the sponsor's and the competitor's products, giving them more coverage than "name, price, quantity", but not creating an impression in the reader's mind of bias, is it advertising? It seems obvious that one...
• Jennifer Carroll -
29 - If a non-profit organization is producing patient support materials funded by an unrestricted grant from a pharmaceutical company (who is completely hands off and has no involvement other than funding), are these materials PAAB-exempt? The materials will be reviewed by a panel of health care practitioners to ensure validity and relevance of the information.
• Jennifer Carroll -
26 - In section 6.1 of the PAAB Code is the following: Journal advertisements are designed to promote an advertiser's products to health professionals via the media of single [11.9] or multi-sponsored publications. Section 11.9 clarifies that: For purposes of this Code, Private/Single Sponsor Journals, newsletters and other publications are defined as any commissioned communication prepared or controlled by the manufacturer or its agent. When can a publication be considered a journal? I ask because I am interested in supporting a single-sponsor publication by placement of an ad, but am uncertain whether this publication is actually a journal or a service-oriented vehicle. Can I place a journal ad in a service-oriented vehicle?
• Jennifer Carroll -
24 - The PAAB Code defines single sponsor publications in section 11.9, and notes in section 6.1 that branded content inserted into same are Journal Advertisement APS. Is the balance of the content of a single-sponsor publication exempt from PAAB review? Or is it considered service-oriented or detail aid APS? What if the ad is placed in a publication for the purpose of sponsorship of an ongoing title offered by an Independent Publisher?
• Jennifer Carroll -
16 - Can a pharmaceutical company distribute a third party piece (a textbook) via their representatives? It is a textbook that they are providing sponsorship for only and thus is exempt from PAAB rules. Does this book require a reference section with the product monograph in it as the product is discussed within the content of the textbook?
• Jennifer Carroll